Parkinson's DiseasePDBIKENCT05298150
Remote Dynamic Cycling for the Customized Off-site Rehab in Parkinson's Disease
A study testing Dynamic cycling and Forced cycling in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This research will develop novel and accessible way to deliver effective and customized rehab to those suffering from common and devastating neurodegenerative condition called Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Dynamic cycling and Forced cycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PD using the UK Brain Bank criteria
- Ability to perform informed consent.
- Hoehn and Yahr (H\&Y) stages I-III when off medication,
- Stable medical regimen of antiparkinsonian medication for at least six months
Who cannot join
- Montreal Cognitive Assessment Scoreless than 18
- Hamilton depression score of 20 or higher
- Hamilton anxiety rating score greater than 24
- Clinical diagnosis including perinatal brain injury, stroke, and atypical parkinsonism
- One or more signs or symptoms of untreated cardiovascular disease including Pain, discomfort in the chest, neck, jaw, arms or other areas that may result from ischemia - Shortness of breath at rest or with mild exertion - Dizziness or syncope - Orthopnea or paroxysmal nocturnal dyspnea - Ankle edema - Palpitations or tachycardia - Intermittent claudication - heart murmur - Unusual fatigue or shortness of breath with usual activity (ACSM Cardiovascular Risk Assessment)
Trial locations and contacts
1 site in 1 country.
United States1 site
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
About this study
This research will develop novel and accessible way to deliver effective and customized rehab to those suffering from common and devastating neurodegenerative condition called Parkinson's disease. The investigators will examine the efficacy of novel rehab technique that can be monitored and modified in real-time but over virtual interface using a remotely located device in a paradigm called dynamic cycling. This technology will benefit thousands of Veterans who need customized and cost-effective rehab but cannot travel to specialized facilities due to inevitable limitations such as pandemics or because of lack of resources, social support, frailty, or home-bound status.
Read the detailed description
Parkinson's disease (PD) progressively deteriorates motor function. Successful rehabilitation, leading to a favorable course of movement disorders in PD, is contingent upon frequent, regular, and patient-specific exercise regimen that is customized to the individual needs. Latter requires regular interventions from the provider and frequent visits to the rehab facility. Lack of access, poor social support, inability to travel, home-bound status, or pandemics are significant hurdles in delivering effective rehab to the PD patients. The investigators' vision is to offer customized and cost-effective PD rehab using a remotely operated technology near or at the patients' homes. This technology would be remotely monitored and customized online to titrate therapeutic outcomes optimized for each patient. The proof of this concept was already established in the investigators' laboratory, a technology called dynamic cycling. The highlight of this technology is a stationary bike operating at a rapid speed (cadence) with programmable variability in speed and power/torque hence promoting motor performance superior to traditional motorized bikes (i.e. static cycling). The next step towards the ultimate vision of at-home exercise therapy is remotely operated dynamic bike. The investigators have already built remotely operated dynamic bike; the current proposal will objectively examine the efficacy of a novel, remotely delivered and remotely adjusted dynamic cycling paradigm using remotely monitored motor outcomes. Comparison will be made with remote static cycling. The study will be launched at three community based wellness locations to assure the subject safety, ease of access, compliance, and as needed support. Aim 1 will examine the hypothesis that dynamic cycling will immediately improve the motor function in PD. The effects will be prominent on the dopamine-sensitive motor deficits. The repetition will enhance motor improvement. The participants will use wearable sensors for the remote assessments of motor symptoms in PD before and immediately after each exercise session. The information from the wearable sensors and the bike will be utilized to further adjust the bike parameters for the next dynamic cycling session. The investigators will also measure effects on subjective ratings of motor function, cognition and balance before, and at 0, 3, and 6 months after the cycling intervention. Aim 2 will analyze the effects of dynamic cycling on motor fluctuations, declining response to levodopa in an early and unpredictable manner significantly affecting the quality of life in the PD. The investigators hypothesize that dynamic cycling will reduce the motor fluctuations in PD. The efficacy of dynamic cycling on improvement in motor fluctuation over a 12-hour awake period will be measured every day with the wearable sensors that communicate via secure cloud. The immediate clinical impact is that the technology will be immediately deployed to the Veteran's group homes, nursing homes, and community based VA clinics. The project will provide sufficient information to carry the investigators' ultimate vision, at-home dynamic cycling serving three critical needs: 1) customized therapy, 2) easy access, and 3) safety and cost-effectiveness.
- Conditions
- Parkinson's Disease
- Being tested
- Dynamic cycling, Forced cycling
- Keywords
- Parkinson's disease, Stationary bike, Exercise, Rehabilitation
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic cyclingOther
The dynamic cycling involves smart bike that changes according to participants' performance.
Forced cyclingOther
The same smart bike as used for dynamic cycling, but its adaptive capacity will be disabled. In this case, the bike will behave as standard exercise stationary bike. It will not change its performance according to participants' response.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic cycling | Experimental | The cycling parameters will change according to motor performance of the participants. Motor performance will be measured by assessing the change in tremor and movement speed. Receives: Other: Dynamic cycling |
| Forced cycling | Active comparator | The cycling parameters will not change regardless of the motor performance. Motor performance will be measured by assessing the change in tremor and movement speed. Receives: Other: Forced cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of abnormal movements measured with wearable sensors (acceleorometers)
- Before and after exercise sensing: Participants will perform finger taps, reaching, extending their arms, and hand opening and closing. As they do so, the investigators will measure their body movements, looking for abnormal involuntary movements, using wearable sensors comprised of accelerometers. Collected data will be used to determine improvement in involuntary movements.
- 12 hour awake period sensing: Participants will wear sensor that looks like a 'wrist watch', and will spend their day in a normal way. Sensor will constantly sense and store their activity measures.
Both sensor outcomes will be transmitted to the laboratory, via secure cloud, for further analysis. The analysis is comprised of looking at change in abnormal movements in response to exercise (cycling) intervention. The change in parameters will be used to further adjust exercise paradigm, if subjects are in dynamic cycling group.
The wearable sensors are non-invasive and highly tolerable.
Measured: Four week
Secondary outcomes (4)
Montreal Cognitive Assessment Scale
We will examine total score of cognitive outcome measure with Montreal Cognitive Assessment Scale before intervention, immediately after (at 4 weeks), 3 months, and 6 months. We will track whether there is any change in the total score after intervention (at mentioned intervals) compared to before intervention. The range of Montreal Cognitive Assessment Scale is between 0 (worst) and 30 (best, that is normal). This is standard and highly tolerable rating scale frequently used in various clinical trials and clinical practice.
Measured: before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention
Berg Balance test
Measure balance outcome measures with Berg Balance test at 0 (i.e., at week 4), 3, and 6 months after the exercise and compare them with pre-exercise baseline. This balance outcome measure depicts change in postural instability in response to exercise regimen, immediately after completion (4 weeks) and at 3 and 6 months. The range is between 0 (worst) and 56 (best, normal). This is standard and highly tolerable rating scale frequently used in various clinical trials and clinical practice.
Measured: before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention
Mini Balance Evaluation System Test
Measure balance outcome measures will be done with Mini Balance Evaluation System Test. It will be done before intervention and at the time of completion of exercise intervention 0 month (4 weeks) and at 3 and 6 month follow up. Post-exercise scores will be compared with pre-exercise baseline. The balance outcome measure depicts change in postural instability and balance in response to exercise regimen. The score ranges between 0 (worst) and 28 (best, normal). This is standard and highly tolerable rating scale frequently used in various clinical trials and clinical practice.
Measured: before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention
Activity-specific Balance Confidence scale
Measure balance function will be performed with Activity-specific Balance Confidence scale. This measure will be performed immediately before the exercise intervention, and after 0 month (at 4 weeks) and at 3 month and 6 months after the exercise and compare them with pre-exercise baseline. The balance outcome measure depicts change in balance function and postural instability in response to exercise regimen. The score ranges from 0 (worst) and 100 (best, normal). This is standard and highly tolerable rating scale frequently used in various clinical trials and clinical practice.
Measured: before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Apr 2022
- Primary completion31 Mar 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exercise intervention
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Aasef G. Shaikh, MD PhD, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298150
- Sponsor's protocol ID
- E3676-R
- Other IDs
- 1I01RX003676-01A2
- Acronym
- PDBIKE
- Status last verified
- Jul 2026
- First submitted
- 8 Mar 2022
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Dynamic Cycling for the Customized Off-site Rehab in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05298150
- Acronym / sponsor ID
- PDBIKE / E3676-R
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Stationary bike, Exercise, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research will develop novel and accessible way to deliver effective and customized rehab to those suffering from common and devastating neurodegenerative condition called Parkinson's disease. The investigators will examine the efficacy of novel rehab technique that can be monitored and modified in real-time but over virtual interface using a remotely located device in a paradigm called dynamic cycling. This technology will benefit thousands of Veterans who need customized and cost-effective rehab but cannot travel to specialized facilities due to inevitable limitations such as pandemics or because of lack of resources, social support, frailty, or home-bound status.
Detailed description
Parkinson's disease (PD) progressively deteriorates motor function. Successful rehabilitation, leading to a favorable course of movement disorders in PD, is contingent upon frequent, regular, and patient-specific exercise regimen that is customized to the individual needs. Latter requires regular interventions from the provider and frequent visits to the rehab facility. Lack of access, poor social support, inability to travel, home-bound status, or pandemics are significant hurdles in delivering effective rehab to the PD patients. The investigators' vision is to offer customized and cost-effective PD rehab using a remotely operated technology near or at the patients' homes. This technology would be remotely monitored and customized online to titrate therapeutic outcomes optimized for each patient. The proof of this concept was already established in the investigators' laboratory, a technology called dynamic cycling. The highlight of this technology is a stationary bike operating at a rapid speed (cadence) with programmable variability in speed and power/torque hence promoting motor performance superior to traditional motorized bikes (i.e. static cycling). The next step towards the ultimate vision of at-home exercise therapy is remotely operated dynamic bike. The investigators have already built remotely operated dynamic bike; the current proposal will objectively examine the efficacy of a novel, remotely delivered and remotely adjusted dynamic cycling paradigm using remotely monitored motor outcomes. Comparison will be made with remote static cycling. The study will be launched at three community based wellness locations to assure the subject safety, ease of access, compliance, and as needed support. Aim 1 will examine the hypothesis that dynamic cycling will immediately improve the motor function in PD. The effects will be prominent on the dopamine-sensitive motor deficits. The repetition will enhance motor improvement. The participants will use wearable sensors for the remote assessments of motor symptoms in PD before and immediately after each exercise session. The information from the wearable sensors and the bike will be utilized to further adjust the bike parameters for the next dynamic cycling session. The investigators will also measure effects on subjective ratings of motor function, cognition and balance before, and at 0, 3, and 6 months after the cycling intervention. Aim 2 will analyze the effects of dynamic cycling on motor fluctuations, declining response to levodopa in an early and unpredictable manner significantly affecting the quality of life in the PD. The investigators hypothesize that dynamic cycling will reduce the motor fluctuations in PD. The efficacy of dynamic cycling on improvement in motor fluctuation over a 12-hour awake period will be measured every day with the wearable sensors that communicate via secure cloud. The immediate clinical impact is that the technology will be immediately deployed to the Veteran's group homes, nursing homes, and community based VA clinics. The project will provide sufficient information to carry the investigators' ultimate vision, at-home dynamic cycling serving three critical needs: 1) customized therapy, 2) easy access, and 3) safety and cost-effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Exercise intervention
| Arm | Type | Receives |
|---|---|---|
| Dynamic cycling | Experimental | Other: Dynamic cyclingThe cycling parameters will change according to motor performance of the participants. Motor performance will be measured by assessing the change in tremor and movement speed. |
| Forced cycling | Active comparator | Other: Forced cyclingThe cycling parameters will not change regardless of the motor performance. Motor performance will be measured by assessing the change in tremor and movement speed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of PD using the UK Brain Bank criteria
- Ability to perform informed consent.
- Hoehn and Yahr (H\&Y) stages I-III when off medication,
- Stable medical regimen of antiparkinsonian medication for at least six months
Key exclusion criteria (5 listed)
- Montreal Cognitive Assessment Scoreless than 18
- Hamilton depression score of 20 or higher
- Hamilton anxiety rating score greater than 24
- Clinical diagnosis including perinatal brain injury, stroke, and atypical parkinsonism
- One or more signs or symptoms of untreated cardiovascular disease including Pain, discomfort in the chest, neck, jaw, arms or other areas that may result from ischemia - Shortness of breath at rest or with mild exertion - Dizziness or syncope - Orthopnea or paroxysmal nocturnal dyspnea - Ankle edema - Palpitations or tachycardia - Intermittent claudication - heart murmur - Unusual fatigue or shortness of breath with usual activity (ACSM Cardiovascular Risk Assessment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic cyclingThe dynamic cycling involves smart bike that changes according to participants' performance. | Other | Dynamic cycling |
| Forced cyclingThe same smart bike as used for dynamic cycling, but its adaptive capacity will be disabled. In this case, the bike will behave as standard exercise stationary bike. It will not change its performance according to participants' response. | Other | Forced cycling |
Primary outcome
Intensity of abnormal movements measured with wearable sensors (acceleorometers)
Time frame: Four week
1. Before and after exercise sensing: Participants will perform finger taps, reaching, extending their arms, and hand opening and closing. As they do so, the investigators will measure their body movements, looking for abnormal involuntary movements, using wearable sensors comprised of accelerometers. Collected data will be used to determine improvement in involuntary movements. 2. 12 hour awake period sensing: Participants will wear sensor that looks like a 'wrist watch', and will spend their day in a normal way. Sensor will constantly sense and store their activity measures. Both sensor outcomes will be transmitted to the laboratory, via secure cloud, for further analysis. The analysis is comprised of looking at change in abnormal movements in response to exercise (cycling) intervention. The change in parameters will be used to further adjust exercise paradigm, if subjects are in dynamic cycling group. The wearable sensors are non-invasive and highly tolerable.
4 secondary outcomes
Montreal Cognitive Assessment Scale
Time frame: before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention
Berg Balance test
Time frame: before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention
Mini Balance Evaluation System Test
Time frame: before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention
Activity-specific Balance Confidence scale
Time frame: before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aasef G. Shaikh, MD PhD principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic cycling and Forced cycling in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of abnormal movements measured with wearable sensors (acceleorometers) (time frame: Four week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.